Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07372131

Antibiotic Duration and Outcomes in High-Risk Febrile Neutropenia Patients

Led by Humanitas University · Updated on 2026-01-28

172

Participants Needed

1

Research Sites

81 weeks

Total Duration

On this page

Sponsors

H

Humanitas University

Lead Sponsor

M

Ministry of education, university and research, Italy

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if a personalized duration of antibiotic therapy, based on clinical stability, is as effective as a standard duration of at least 10 days in hospitalized patients with hematologic malignancies (such as leukemia or lymphoma) who develop febrile neutropenia and Gram-negative bacteraemia. The main questions it aims to answer are: * Can a personalized antibiotic duration increase the number of days free from anti-Gram-negative therapy within 28 days without compromising patient safety? * How does the duration of antibiotic therapy (short vs. prolonged) affect the rate and modality of gut microbiota reconstitution? Researchers will compare: * Group A (Personalized Duration): Antibiotics are stopped after the patient maintains clinical stability (no fever and stable vital signs) for 72 consecutive hours. * Group B (Standard of Care): Antibiotics are continued for a standard duration, typically at least 10 days, based on current clinical surveys and physician decision. Participants will: * Be randomized to receive either the personalized or the standard duration of antibiotic therapy once a Gram-negative infection is confirmed in the blood. * Be monitored for 28 days to assess for new fever episodes, recurrence of infection, and overall survival. * If participating in the microbiological sub-study, provide biological samples (blood, feces, and rectal swabs) at specific time points (at the onset of fever, at the end of treatment, and at day 28). * Undergo specialized laboratory testing (Whole Metagenomic Sequencing) on the collected samples to evaluate the evolution of their intestinal and blood microbiota and the presence of antibiotic-resistant genes.

CONDITIONS

Official Title

Antibiotic Duration and Outcomes in High-Risk Febrile Neutropenia Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with a hematologic malignancy eligible for chemotherapy, bone marrow transplant, or CAR-T therapy
  • Febrile neutropenia defined by fever (oral temperature ≥38.3°C once or ≥38.0°C sustained for 1 hour) and neutropenia (absolute neutrophil count < 1000 cells/microL)
  • Expected duration of neutropenia of 7 days or more
  • Bacteraemia diagnosed by positive blood cultures for non-contaminant microorganisms
  • Isolation of Gram-negative bacterial species
Not Eligible

You will not qualify if you...

  • Diagnosis of pneumonia
  • Diagnosis of intra-abdominal infections including neutropenic enterocolitis or biliary tract infection
  • Persistently positive blood cultures at time of randomization
  • Any condition deemed unsafe by the treating physician

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Microbiology and Virology - IRCCS Humanitas Research Hospital

Rozzano, Milan, Italy, 20089

Actively Recruiting

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Research Team

V

Valeria Cento, MD, PhD

CONTACT

M

Michele Bartoletti, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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